CClinicalTrials.gg
Status unknownNCT05423236Updated Jun 21, 2022

Clinical Characteristics of Lung Cancer in China

An observational study in Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
119,785
Sex
All
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Study summary

This study is a single-center, real-world and large-population-based retrospective study. In the current study, the investigators not only describe the changes of demographic and basic clinicopathological characteristics of lung cancer during recent years but delineate the correlation between clinicopathological features and common clinical blood tests in such a large population.

Read the detailed description

In this study, the investigators will collected all lung cancer patients diagnosed in Shanghai Pulmonary Hospital from 2012 to 2020. By conducting this population based study, the investigators would like to delineate changes of characteristics of lung cancer in Chinese patients during these years. Meanwhile, the investigators will compare clinicopathological features, routine blood tests, blood biochemical tests and coagulation status among participants at different stages. This comparing will assist the investigators to understand systemic changes during lung cancer progression. The same comparison will also be conducted among participants having different driver mutation through which the investigators will further understand the characteristics of different patients and treat patients more precisely.

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Conditions studied

  • Lung Cancer

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Keywords

  • Cross-sectional Study
  • Clinical Characteristics
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 119,785 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population was patient who was diagnosed as lung cancer at Shanghai Pulmonary Hospital from January 1st, 2012 to October 31st, 2020.

Inclusion criteria

  1. Patients have medical records in our hospital.
  2. Patients were diagnosed as lung cancer by pathological examination.

Exclusion criteria

Exclusion Criteria:

  1. Patients were lack of accurate pathological diagnoses.
  2. Pathological diagnosis was benign disease or metastatic cancer from other organs.
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
119,785 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Comprehensive analysis of clinical characteristics of lung cancer of all participants

    The changes of demographic characteristics and clinicopathological characteristics of Chinese lung cancer patients during the 8 years, from 2012 to 2020, will be analyzed.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  2. Measurement of prothrombin time (PT) would be performed in all participants

    The investigators collected the prothrombin time (PT) (the unit is second). Then the investigators would compare PT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  3. Measurement of activated partial thromboplastin time (APTT) would be performed in all participants

    The investigators collected the activated partial thromboplastin time (APTT) (the unit is second). Then the investigators would compare APTT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  4. Measurement of thrombin time (TT) would be performed in all participants

    The investigators collected the thrombin time (TT) (the unit is second). Then the investigators would compare TT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  5. Measurement of fibrinogen would be performed in all participants

    The investigators collected the blood fibrinogen content (the unit is gram per liter). Then the investigators would compare blood fibrinogen content among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  6. Measurement of D-dimer would be performed in all participants

    The investigators collected the blood D-dimer content (the unit is nanogram per milliliter). Then the investigators would compare blood D-dimer content among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  7. Measurement of fibrinogen degradation product (FDP) would be performed in all participants

    The investigators collected the blood fibrinogen degradation product (FDP) (the unit is microgram per milliliter). Then the investigators would compare blood FDP content among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  8. Complete blood cell count (CBC) would be performed in all participants

    The investigators collected the result of complete blood cell count (CBC) of all participants. Then the investigators would compare CBC results among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  9. Renal function test would be performed in all participants

    The investigators collected the result of creatinine (the unit is micromole per liter) of all participants. Then the investigators would compare creatinine level among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  10. Alanine aminotransferase would be measured in all participants

    The results of measurement of alanine aminotransferase (ALT) (the unit is unit per liter) would be collected. Then the investigators would compare ALT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  11. Aspartate aminotransferase would be measured in all participants

    The results of measurement of aspartate aminotransferase (AST) (the unit is unit per liter) would be collected. Then the investigators would compare AST among the participants having different driver mutation. Meanwhile, these would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  12. Alkaline phosphatase would be measured in all participants

    The results of measurement of alkaline phosphatase (ALP) (the unit is unit per liter) would be collected. Then the investigators would compare ALP among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  13. Gamma-glutamyl transferase would be measured in all participants

    The results of measurement of gamma-glutamyl transferase (GGT) (the unit is unit per liter) would be collected. Then the investigators would compare GGT among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

Secondary outcomes

  1. Blood electrolyte level would be tested

    The investigators collected the result of sodium, potassium, calcium, chloride, phosphate and magnesium (the unit is millimole per liter) of all participants. Then the investigators would compare these among the participants having different driver mutation. Meanwhile, these would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  2. Measurement of total glycerol would be performed

    The investigators collected the result of total glycerol (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  3. Measurement of total cholesterol would be performed

    The investigators collected the result of total cholesterol (the unit is micromole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  4. Measurement of low density lipoprotein cholesterol (LDL-C) would be performed

    The investigators collected the result of LDL-C (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  5. Measurement of high density lipoprotein cholesterol (HDL-C) would be performed

    The investigators collected the result of HDL-C (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

  6. Fasting blood glucose (FBG) test would be performed

    The investigators collected the result of FBG (the unit is millimole per liter) of participants. Then the investigators would compare it among the participants having different driver mutation. Meanwhile, it would also be compared among the participants at different stage.

    Time frame: The data will be collected from medical records in recent 8 years from 2012 to 2020. And investigators will analyze these data in the following 1 year.

07

Study locations

1 site
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai 200433, China
    • Yayi He, PhD, MD · Contact · doctorjael@qq.com · +86 021-65115006
    • Yayi He, PhD, MD · Principal investigator
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References and documents

Publications

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. PubMed 33433946 ↗
  • Al-Samkari H, Leiva O, Dagogo-Jack I, Shaw A, Lennerz J, Iafrate AJ, Bendapudi PK, Connors JM. Impact of ALK Rearrangement on Venous and Arterial Thrombotic Risk in NSCLC. J Thorac Oncol. 2020 Sep;15(9):1497-1506. doi: 10.1016/j.jtho.2020.04.033. Epub 2020 May 11. PubMed 32437899 ↗
  • Roopkumar J, Poudel SK, Gervaso L, Reddy CA, Velcheti V, Pennell NA, McCrae KR, Khorana AA. Risk of thromboembolism in patients with ALK- and EGFR-mutant lung cancer: A cohort study. J Thromb Haemost. 2021 Mar;19(3):822-829. doi: 10.1111/jth.15215. Epub 2021 Jan 24. Erratum In: J Thromb Haemost. 2021 Nov;19(11):2902. doi: 10.1111/jth.15482. PubMed 33314597 ↗
  • Zhu VW, Zhao JJ, Gao Y, Syn NL, Zhang SS, Ou SI, Bauer KA, Nagasaka M. Thromboembolism in ALK+ and ROS1+ NSCLC patients: A systematic review and meta-analysis. Lung Cancer. 2021 Jul;157:147-155. doi: 10.1016/j.lungcan.2021.05.019. Epub 2021 May 20. PubMed 34049720 ↗
  • Qian X, Fu M, Zheng J, Zhou J, Zhou J. Driver Genes Associated With the Incidence of Venous Thromboembolism in Patients With Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 29;11:680191. doi: 10.3389/fonc.2021.680191. eCollection 2021. PubMed 33996610 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05423236
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Responsible party
Yayi He (Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Jun 21, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Jun 21, 2022

Study contacts

Yayi He, PhD, MD
Contact
doctorjael@qq.com
+86 021-65115006

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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